Neurologic Complication

further processing of biological materials and health related personal data for research

further processing of health data

University Hospital Zurich

Neuro-COVID-19: Neurological Complications of COVID-19

Determine the prevalence of neurological complications in hospitalized COVID-19 patients admitted to the intensive care unit.

Examine if empiric COVID-19 therapies are associated with difference in the prevalence and outcome of severe neurological complications of COVID-19.

Determine the impact of neurological complications among COVID-19 patients on mortality, functional outcome, and organizational outcomes (ICU length of stay, hospital length of stay) among patients with confirmed COVID-19.

Analyze characteristic patterns in cerebral imaging and electroencephalography (EEG), as well as cerebrospinal fluid (CSF) of patients, in whom a lumbar puncture has been performed for clinical reasons

Analyze the brain for pathological changes and histopathological findings, if the patient dies.

Emanuela Keller

Prof. Dr. Emanuela Keller

volunteers will receive once daily cobicistat for 5 days. On day 5, participants will receive a single oral dose of GHB. After a washout period for 7 days, volunteers will receive once-daily placebo for 5 days. On day 5, participants will receive a single oral dose of GHB

volunteers will receive once-daily placebo for 5 days. On day 5, participants will receive a single oral dose of GHB. After a washout period for 7 days, volunteers will receive once daily cobicistat for 5 days. On day 5, participants will receive a single oral dose of GHB.

Pharmacokinetic Interactions

once daily cobicistat (150 mg QD) for 5 days

Cobicistat 150 MG

once daily lactose capsules (as aspect cobicistat capsules)

Placebo

single oral dose of GHB (25 mg/kg) on days 5 and 17

José

Clinical Trial to Evaluate Pharmacological Interactions Between γ-hydroxybutyrate (GHB) and Cobicistat

% of participants developing related adverse events.

Addiction Research Center Inventory (ARCI) 49 item short for questionnaire (measures sedation, euphoria, dysphoria, energy and stimulation)

visual analog scales (VAS) 15 items (about sensations (good or bad), feelings, nausea and vomit) determined by horizontal line of 100 mm. The ends are defined as the limits of the parameter to be measured orientated from the left (minimum intensity) to the right (maximum intensity).

Fundacio Lluita Contra la SIDA

Participants will undergo two 5-day treatment periods (COBI and placebo) separated by a 7-day washout period:
COBI period: volunteers will receive once daily cobicistat (150 mg QD) for 5 days.
Placebo period: volunteers will receive once-daily placebo (lactose) for 5 days. On day 5 of each treatment period, participants will receive a single oral dose of GHB (25 mg/kg).

Lacosamide: Subjects randomized to lacosamide according to the following schedule:
Treatment Phase Week Dose Week 1 LCM 50 mg bid Week 2 LCM 100 mg bid Week 3 LCM 150 mg bid Week 4 LCM 200 mg bid

Lacosamide

Placebo: Placebo will be packaged identically to experimental drug and titrated according to the same schedule.

Sugar Pill

Total

Gender

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Region of Enrollment

Scale 0 - 24 Higher scores indicate more severe symptoms

Change in Epworth Sleepiness Scale Score From Baseline to Visit 4

Fatigue Severity Scale (FSS): Range 7- 63 where higher scores indicate more severe fatigue.

Change in the Fatigue Severity Scale From Baseline to Visit 4.

Range 0-21, where higher scores more impairment (in terms of sleep quality).

Change in Pittsburgh Sleep Quality Inventory (PSQI) From Baseline to Visit 4

Range 0-20 where lower scores indicate more impairment (sleep related QOL).

Change in Functional Outcomes of Sleep Questionnaire (FOSQ) From Baseline to Visit 4.

Range 19-76, where higher scores indicate more severe impairment (in terms of 19 common antiepileptic drug side effects.

Change in Adverse Event Profile (AEP) From Baseline to Visit 4.

Range 0-27, where higher scores indicate more impairment (depressive symptoms)

Change in Patient Health Questionnaire-9 (PHQ-9) From Baseline to Visit 4.

Change in Daily Seizure Frequency From Baseline to Visit 4

Range 0 -10 where higher scores reflect better quality of life.

Change in Quality of Life in Epilepsy (QOLIE-31) From Baseline to Visit 4

Overall Study

Nancy Foldvary-Schaefer, DO, MS

Partial Epilepsy

Subjects randomized to lacosamide according to the following schedule:
Treatment Phase Week Dose Week 1 LCM 50 mg bid Week 2 LCM 100 mg bid Week 3 LCM 150 mg bid Week 4 LCM 200 mg bid

Placebo will be packaged identically to experimental drug and titrated according to the same schedule.

Cleveland Clinic

Randomized Controlled Trial to Assess Effects of Lacosamide on Sleep and Wake in Adults With Focal Epilepsy

Searching for "Sleep Friendly" Therapies for a Sleepy Population: A Double-Blind, Placebo-Controlled, Randomized Trial to Assess the Effects of Lacosamide on Sleep and Wake in Adults With Focal Epilepsy

narcolepsy/seizures

Neuro-COVID-19: Neurological Complications of COVID-19

Clinical Trial to Evaluate Pharmacological Interactions Between γ-hydroxybutyrate (GHB) and Cobicistat

Randomized Controlled Trial to Assess Effects of Lacosamide on Sleep and Wake in Adults With Focal Epilepsy

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